NCT00004771

Brief Summary

OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1992

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Spinal Muscular AtrophyAmyotrophic Lateral SclerosisSpinobulbar Muscular Atrophy

Keywords

amyotrophic lateral sclerosismotor neuron diseaseneurologic and psychiatric disordersrare diseasespinal and bulbar muscular atrophyspinal muscular atrophyKennedy's Syndrome

Interventions

leuprolideDRUG
testosteroneDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Men aged 18 and over with motor neuron disease, i.e.: * X-linked spinal and bulbar muscular atrophy (Kennedy's disease) * Confirmed by androgen receptor, exon-1 mutation genotype * Amyotrophic lateral sclerosis * Spinal muscular atrophy Significant muscle weakness on manual muscle testing No prisoners No mental disability

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Atrophy, SpinalAmyotrophic Lateral SclerosisBulbo-Spinal Atrophy, X-LinkedMotor Neuron DiseaseNeurologic ManifestationsMental DisordersRare Diseases

Interventions

LeuprolideTestosterone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeuromuscular DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHeredodegenerative Disorders, Nervous SystemGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Jerry R. Mendell

    Ohio State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

October 1, 1992

Last Updated

June 24, 2005

Record last verified: 2001-12